Cut-off criteria under Regulation 1107/2009/EC

What are cut-off criteria ?

The cut-off criteria prevents the approval or re-approval of active substances for which particular types of danger are present. Substances that meet any of the cut-off criteria are rejected without considering the results of the risk assessment.

There are four toxicological cut-off criteria.

There are three environmental cut-off criteria.

What ENC can do?

We can assess if a particular substance will meet the cut-off criteria before it goes under EU evaluation, e.g.

• Providing a feasibility study for the renewal of first approval of an active substance may include the assessment of the cut-off criteria.
• The data gap analysis should determine if new data must be generated or accessed to assess the cut-off criteria.
• Writing an active substance dossier must include a detailed draft assessment of these criteria.